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Therapeutic Development


Now more than ever, expediting therapeutic development is critical in the fight against COVID-19. Whether you are developing an antibody, inhibitor, antiviral, or cell therapy, we have solutions to help accelerate your discovery and development, without compromising the quality, efficacy, and safety of your therapeutic.

Cell Line Development

Genetic Stability for Protein and Virus Expression

Stable, high-producing cell lines are critical to ensure the scalable production of protein therapeutics or viral constructs. Monitoring the genetic stability of master cell banks and producer cell lines demonstrates quality and safety over time. Limitations in precision can cause uncertainty during cell line characterization and expansion.

Droplet Digital PCR (ddPCR) offers the ability to confidently and reproducibly determine gene vector copy number to assess the stability and safety of your cell lines and assure productivity.

Gene-edit Screening

Cell line engineering holds immense potential for rapid cell line development. Technologies like CRISPR gene editing, zinc-finger nucleases (ZFN) and transcription activator-like effector nucleases (TALEN) offer immense potential in cell line development. Due to the low efficiency of gene editing, sensitive detection is necessary for clonal screening.

Droplet Digital PCR complements cell line engineering by providing sensitive detection of positive clones as well as characterizing the expected frequency of homologous recombination. Paired with gene-editing technology, ddPCR enables sensitive streamlined approaches in cell line development.

Cell Screening for Clonal Selection

Creating highly-productive cell lines involves significant screening, with one important parameter being cell-specific productivity. Analysis methods that enable the characterization of an individual cell’s phenotype can identify characteristics and culture conditions that allow for optimal cell-specific productivity. It is crucial to identify clones for production to expedite therapeutic candidate selection readily.

The ZE5 Cell Analyzer provides speed, sensitivity, sample handling flexibility, and high-parameter multiplexing, all while offering maximal productivity.

INCREASE SPEED
Analyze 384 well plate in less than 60 min with acquisition speed of 100K events/sec
GAIN VERSATILITY
Integrated sample loader to easily switch between tubes and plates
MAXIMIZE THROUGHOUT
Application programing interface (API) available for automation integration and 24/7 operation

Learn how to discover more with flow cytometry, click here ▸

High-Throughput Flow Cytometry

This webinar is focused on the ZE5 Cell Analyzer's innovative designs in hardware and software to empower its automation and high-throughput capabilities. Its smart technology and automation-readiness make the ZE5 an ideal solution for automated high-throughput flow cytometry needs.

Vector Copy Number for Cell Therapies

Accurate vector copy number is an important characterization when trying to achieve ideal dosing, as it has implications in therapeutic efficacy and risk. Traditional qPCR provides a relative measurement and requires many replicates.

The high-precision absolute quantification of ddPCR enables the detection of small fold copy number changes providing confidence in discriminating between integration events beyond 3 copies.

Immune-mediated Response

Cell Screening and Phenotyping

Characterizing cell types and cellular behavior involved in the immune response to viral infection is of paramount importance for the creation of therapeutic treatments. These cell-based assays help researchers to glean insights into what they may observe in preclinical and clinical studies. Additionally, the ability to readily screen therapeutic drug candidates, be it antivirals or neutralizing antibodies, is essential to find targets quickly. At the same time, the signatures that characterize these immune responses can be complex. These multiplex, large-scale assays can benefit from automated high-throughput, high-parameter in order to identify treatments faster.

The ZE5 allows for high-throughput, high-parameter flow cytometry phenotyping to identify and characterize immune responses as a result of therapeutic treatment.

For a complete listing of our antibodies for innate and adaptive immune responses click here ▸

Bioanalysis

Development, validation, and implementation of robust and accurate bioanalytical assays, such as pharmacokinetic and anti-drug antibody assays, are essential to determine safety and efficacy. Having a highly specialized reagent is critical for detecting the therapeutic in complex in vivo samples.

Using Bio-Rad's HuCAL monoclonal antibody generation services, customized anti-idiotypic antibodies can be developed to sensitively detect the therapeutic drug in the presence of the patient's own immunoglobulins. Derived from a fully synthetic human library, HuCAL antibodies are also ideal for use as a reference standard in immunogenicity assays.

Advantages of using Bio-Rad’s custom HuCAL monoclonal antibody generation services:

  • Highly specific, high affinity antibodies
  • Guided selection allowing for specific binding and blocking
  • Affinity maturation if higher sensitivity is required
  • Antibody sequence available for security of supply and independence
  • Antibodies available in as little as 8 weeks

Learn more about custom recombinant monoclonal antibody generation ▸

Impurities Detection

The FDA requires the reporting and quantification of host cell protein (HCP) and host cell DNA (HCD) in biologics since it can affect the efficacy and toxicity of the final product. Levels of these materials are critically monitored during process development and validation.

The GS-900 Calibrated Densitometer has been designed and validated to quantitate the levels of HCP impurities.

Biologics Analysis Workflow ▸

FLEXIBLE
Compatible with a wide variety of protein stains including Coomassie and silver stain
ACCURATE
Internal calibration using NIST-traceable step tablets
GMP COMPLIANT
Automated analysis using Image Lab Software with 21 CFR Part 11 compliance with available installation qualification/operational qualification (IQ/OQ) protocols

Droplet Digital PCR provides a highly sensitive method for direct quantification of residual HCD to ensure adherence to the FDA guideline of < 100 pg/dose. With ddPCR:

  • No DNA purification required
  • Inhibitor tolerance to in-process low pH and high salt sample matrices
  • Available optimized supermix free of detectable E. coli, CHO, mouse, human and yeast DNA

Supporting publications:

Method for Residual DNA Quantification that Eliminates DNA Extraction, Protease Digestion and Use of DNA Standards

Viral Load Monitoring

Viral load is the measurement of viral particles in a patient. During clinical trials, monitoring the viral load is essential in indicating the therapeutic efficacy of a drug for the treatment of COVID-19. The precise quantification of viral particles is a critical indicator of patient response.

Droplet Digital PCR provides an ultra-sensitive and highly-precise absolute quantification of nucleic acid sequences. The sensitivity and precision ensure reproducible results with minimal lab-to-lab variability. ddPCR measures absolute quantities by counting nucleic acid molecules encapsulated in discrete and volumetrically defined water-in-oil droplet partitions. Droplet Digital PCR is particularly useful for low-abundance targets, targets in complex backgrounds, and monitoring subtle changes in target levels undetectable by real-time PCR. The SARS-CoV-2 ddPCR test is based on highly sensitive and precise Droplet Digital PCR technology and is optimized for use on Bio-Rad Droplet Digital PCR Systems.

  • High sensitivity and precision in low viral abundance samples
  • Resistant to inhibition often seen in RT-PCR testing
  • Single-well test — 3 sequences aligned to CDC markers: SARS-CoV-2 N1 and N2 genes, human RPP30 gene

Using Droplet Digital PCR to Quantify Levels of HIV Reservoirs

Dr Gary Lee, Senior Scientist at Sangamo BioSciences, Inc., and his team use Bio-Rad's Droplet Digital PCR system to quantify the level of HIV reservoirs in patients treated with their unique zinc-finger-based HIV therapy. With the need to detect approximately one copy of HIV in 1,000 cells analyzed, this quantification would present a challenge for conventional methods.

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